FDA.reportPublic FDA data

Ibuprofen

Product NDC
25000-121
11-digit product format
250000121
Labeler code
25000
Product ID
25000-121_06380458-ba55-458e-b6f8-e6219af48f32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA090796
Marketing category
ANDA
Marketing start
2011-02-28
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-121-03Ibuprofen30 in 1 BOTTLETABLET3015
25000-121-12Ibuprofen500 in 1 BOTTLETABLET50015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QMPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
PrasteroneACTIVE INGREDIENT459AG36T1BPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
ibuprofenACTIVE MOIETYWK2XYI10QMPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
PrasteroneACTIVE MOIETY459AG36T1BPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
gelatinINACTIVE INGREDIENT2G86QN327LPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
lecithin, soybeanINACTIVE INGREDIENT1DI56QDM62PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
soybean oilINACTIVE INGREDIENT241ATL177APRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
TALCINACTIVE INGREDIENT7SEV7J4R1UPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
yellow waxINACTIVE INGREDIENT2ZA36H0S2VPRASTERA (PRASTERONE AND IBUPROFEN) KIT [HEALTH SCIENCE FUNDING, LLC]13
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-121IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20241023_e54209c2-f726-440b-ac60-5a72710d2a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197806ibuprofen 600 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197807ibuprofen 800 MG Oral TabletPSNe54209c2-f726-440b-ac60-5a72710d2a9b15
197805ibuprofen 400 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15
197806ibuprofen 600 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15
197807ibuprofen 800 MG Oral TabletSCDe54209c2-f726-440b-ac60-5a72710d2a9b15
197805ibuprofen 400 MG Oral TabletPSNd509cc4f-d92f-4216-a117-16b467a2912613
197805ibuprofen 400 MG Oral TabletSCDd509cc4f-d92f-4216-a117-16b467a2912613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-121-032500001210330 TABLET in 1 BOTTLE (25000-121-03) 30 tablet2011-02-280000-00-00NoNoCurrent
25000-121-1225000012112500 TABLET in 1 BOTTLE (25000-121-12) 500 tablet2011-02-280000-00-00NoNoCurrent
25000-121-19250000121194 BAG in 1 BOX (25000-121-19) > 3500 TABLET in 1 BAG4 bag2011-02-280000-00-00NoNoCurrent
25000-121-29250000121296 BAG in 1 BOX (25000-121-29) > 3500 TABLET in 1 BAG6 bag2011-02-280000-00-00NoNoCurrent
25000-121-93250000121931 BAG in 1 BOX (25000-121-93) > 18735 TABLET in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent
25000-121-98250000121981 BAG in 1 BOX (25000-121-98) > 17030 TABLET in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent